Evommune Initiates Phase 2a Proof-of-Concept Clinical Trial of EVO101 in AD

September 28, 2022

EVO101 is a novel small molecule inhibitor of interleukin 1 receptor-associated kinase 4 (IRAK4).

Evommune, Inc. enrolled the first patient in a Phase 2a proof-of-concept clinical trial evaluating EVO101, a novel small molecule inhibitor of interleukin 1 receptor-associated kinase 4 (IRAK4), in patients with atopic dermatitis (AD). 

The Phase 2a trial is a randomized, double-blind, parallel group, vehicle-controlled study which will assess the safety, tolerability and preliminary efficacy of EVO101 topical cream, 0.1% BID, in 118 adults with mild to moderate AD in clinical sites across the United States.

"People with AD often deal with incessant itch and painful skin which can disrupt sleep and lead to an overall lower quality of life. Additionally, its systemic nature means that AD is associated with a number of other serious inflammatory co-morbidities, including asthma, infection and mental health issues,” says Eugene A. Bauer, M.D., Chief Medical Officer of Evommune, in a news release. "Safer and more effective treatments that prevent disease progression and broadly inhibit inflammation are needed for these patients. Given EVO101's mechanism of action and the compelling preclinical and Phase 1 data, we believe that further study is well warranted and that it could, if approved, become a best-in-class treatment."

The Phase 2a study follows the successful completion of a Phase 1 healthy volunteer study which evaluated 18 adult patients with EVO101 0.1% topical cream, applied twice daily to the ventral aspect of one forearm for seven days. EVO101 was well-tolerated in all participants. In the Phase 2a study, AD patients will apply EVO101 cream twice daily for eight weeks. Primary efficacy will be assessed by changes from baseline in the Eczema Area and Severity Index (EASI).

"From inception, we have remained focused on rapidly progressing multiple candidates into proof-of-concept clinical studies," says Luis Peña, President and Chief Executive Officer of Evommune. "Our team is delivering on the first of four ongoing programs with this trial's initiation and we look forward to sharing data from this robust proof-of-concept trial in the first half of next year."

More on EVO101

EVO101 is a novel, small molecule inhibitor of interleukin 1 receptor-associated kinase 4 (IRAK4). This protein plays a key role in innate immune responses, as it is critical for both Toll-like receptor and IL-1 family cytokine signaling. Importantly, IL-1 family cytokines also amplify and drive adaptive inflammatory responses. EVO101 has been shown to potently inhibit inflammation in animal models, and in a variety of human skin models of innate and adaptive immunity. IRAK4 is viewed as a valuable target for the treatment of a broad range of inflammatory diseases. While the initial focus will be on studying EVO101 in atopic dermatitis, it also may have utility in the treatment of Behçet's disease, pustular psoriasis, ocular rosacea and conjunctivitis. The inhibition of IRAK4 signaling is expected to broadly and potently suppress inflammation and provide rapid resolution of symptoms.

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